Paediatric regulation: From PIP to rewards

21st March 2018,
London, United Kingdom

This workshop gives a regulatory/ legal perspective on paediatric investigation plans, the paediatric procedure, other obligations imposed by paediatric regulation, the sanctions for non-compliance and the rewards.
We will start with the very first question of whether a PIP is required and end with the very last stage of applying for a reward. We will also examine the best practices with regard to the content of a PIP and the procedure.

• Gain detailed insight into the EU paediatric legislation
• Understand the overall functioning of the paediatric system and the best approaches thereto
• Learn about the best practices when defining the content of the PIP
• Learn about the best practices when dealing with regulatory procedures
• Maximise the chances of obtaining a reward

Workshop
LEADER

Genevieve Michaux

Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Mayer Brown LLP

At Mayer Brown We offer the legal and technical experience and global awareness needed to understand the opportunities offered and challenges presented to these industries.

Our Life Sciences group consists of a multidisciplinary team of lawyers with extensive industry knowledge and resources. The group comprises lawyers from across the firm’s practices. These lawyers are experienced in dealing with the issues affecting the life sciences industries globally, including: transactions, intellectual property (IP), dispute resolution, antitrust and competition, risk management, investigations and compliance, government and global trade, tax and transfer pricing, and regulatory and environmental matters.

Workshop
programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

9:10 SESSION 1 – Do I need a PIP?

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Exemptions

New active substances

'Old' (authorised) active substances

9:50 SESSION 2 – What should the PIP cover?

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

EMA Policy on the Content of the PIP

Waiver

Deferral

10:30 Morning Coffee

11:00 SESSION 3 – Procedures

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Paediatric Procedure: PIP and PIP modification

Interactions with the Marketing Authorisation Procedure: from compliance check to authorisation of a paediatric indication

11:40 SESSION 4 – Rewards

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Extension of supplementary protection certificate (SPC) protection

Orphan products: extension of market exclusivity protection

PUMA

How to maximise the chances of obtaining a reward

12:20 Closing Remarks

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.

Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.

Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

13:50 End of workshop

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

SAVE TO

Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

Cookie Policy

From May 2011 a new privacy law came into effect across the EU. The law requires
that websites ask visitors for consent to use most web cookies. We use cookies to
ensure you get the best experience on our website –Tick here to accept cookie use
Details of our cookie use may be found here.

WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy,
which maintains that in order to be effective, learning should be organised and
structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional
competence’

CPD is a common requirement of individual membership with professional bodies and
Institutes. Increasingly, employers also expect their staff to undertake regular
CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do
not become obsolete, and allows for best practice and professional standards to
be upheld.

CPD can be undertaken through a variety of learning activities including instructor
led training courses, seminars and conferences, e:learning modules or structured
reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with
a collective membership of circa 4 million professionals, and they all expect their
members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked
to a licence to practice, for others it’s obligatory. By ensuring that their members
undertake CPD, the professional bodies seek to ensure that professional standards,
legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide
online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’
or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve
within a given time period. These schemes can also use different ‘currencies’ such
as points, merits, units or credits, where an individual must accumulate the number
required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of
learning.

‘Output’ based schemes are learner centred. They require individuals to set learning
goals that align to professional competencies, or personal development objectives.
These schemes also list different ways to achieve the learning goals e.g. training
courses, seminars or e:learning, which enables an individual to complete their CPD
through their preferred mode of learning.

As a formal provider of CPD certified activities, SMI Group can provide an indication
of the learning benefit gained and the typical completion. However, it is ultimately
the responsibility of the delegate to evaluate their learning, and record it correctly
in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces
and looking to the UK to benchmark educational standards. The undertaking of CPD
is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk